October 28, 2015 – – ZofranLegal.com reports on another lawsuit filed against GlaxoSmithKline concerning their drug Zofran. This suit, filed by a Minnesota mother, claims that the anti-nausea drug caused both of her children to suffer congenital heart defects. The lawsuit, number 2:15-CV-00709PD, states that the plaintiff used Zofran during the first trimester of both pregnancies to combat morning sickness, and subsequently, her children suffered from serious birth defects.

When Zofran is prescribed to pregnant women, this is termed an “off-label” prescription, as it was not approved by the U.S. Food and Drug Administration to treat expectant mothers. Additionally, the product was never tested and approved as safe for use by pregnant women. The drug was FDA approved to treat individuals experiencing episodes of extreme nausea and vomiting after undergoing chemotherapy, radiation, or anesthesia procedures.

After the drug’s initial approval, however, manufacturer GlaxoSmithKline began marketing it to pregnant mothers as a means to combat their morning sickness. Many complaints allege that this was done despite knowledge that the drug was linked to an increased likelihood of birth defects in children born whose mothers used Zofran while pregnant.

In this particular complaint, the plaintiff alleges that her first child, born prematurely in 2004, suffered a congenital heart defect and significant developmental delays due to that defect because of Zofran. The child was born with a cardiac septal defect, indicating that there was a hole in the infant’s heart. This defect requires surgery.

The second child, born in 2006 after the plaintiff had again used Zofran while pregnant, was also born with a heart defect. The infant required 24-hour monitoring as the defect caused her difficulty breathing. The infant also experience delayed growth due to the defect.

After both of her children suffered from heart defects, the plaintiff began to look into Zofran. With no familial history of birth defects or heart problems, she started to become concerned with the safety of the drug. In both pregnancies, she had used it during the first trimester, a time when the heart experiences significant formation. As she researched Zofran, the plaintiff noticed several studies linking the drug to various birth defects. She became upset that she had not been warned about the alleged risks by her doctors or GSK, and indicated that, had she known about the studies sooner, she would have never used the drug.

Across the United States, there are now over 60 parents who have stepped up to allege similar complaints after using Zofran while pregnant. The Zofran attorneys at Monheit Law are working diligently to ensure that anyone who has used the drug while expecting and has subsequently given birth to a child with defects is able to explore their legal rights. They are currently providing free evaluations for anyone involved.

For more information on this topic or other connected birth defect lawsuits, please contact Michael Monheit, Esq. at 877-620-8411.